BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 11369460 · Received February 23, 2021

    Report

    Report Number
    2017865-2021-09076
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 23, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    UDI-DI
    05415067027320
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC REMOTELY VIA MERLI.NET TRANSMISSION WITH FALSE EPISODES OF CARDIAC PAUSES OBSERVED ON THE IMPLANTABLE CARDIAC MONITOR. IT WAS THE DETERMINED THAT THE EPISODES WERE ACTUALLY CAUSED BY R WAVE UNDERSENSING. THE CLINICIAN ELECTED TO CONTINUE TO MONITOR THE PATIENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263063 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM3500 P000093483 05415067027320

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR